Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2020-07-09
2023-09-14
Brief Summary
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Aim 1 - To examine and characterize the threshold of the exposure (PK) vs. response (PD) relationship of PMO (menthol)
Aim 2 - PD of PMO as assessed by:
1. Microbiome composition (16S RNA sequencing)
2. Transit rate/contractile activity (using the SmartPill®) Aim 3 - Evaluate the potential association between PD response and clinical symptoms (abdominal pain and stooling pattern via validated diary), psychosocial distress (anxiety, depression, somatization), and characterize potential side effects (questionnaire)
Detailed Description
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Following the single-dose PK study, a PD study will be carried out wherein the subjects will receive their assigned dose of PMO for 7 days.
At baseline (before the PK study) and after the PK study (i.e., during the PD study), subjects will keep a pain and stooling diary, collect stool for microbiome analysis, and swallow a SmartPill to measure gut motility and transit time. At baseline only, anxiety, depression, somatization will be measured. During the PD study, any side effects will be recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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540 mg
Peppermint oil at a dose of 180 mg thrice daily orally
Peppermint oil
Administration of peppermint oil at one of two daily doses.
900 mg
Peppermint oil at a dose of 180 mg five times daily orally
Peppermint oil
Administration of peppermint oil at one of two daily doses.
Interventions
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Peppermint oil
Administration of peppermint oil at one of two daily doses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to complete the diaries which have been validated for use in this age range
* The history and medical evaluation reveal no organic reason for the abdominal pain
* The child has abdominal pain that meets the definition of FAP according to pediatric Rome IV
* Ability to understand study procedures and to comply with them for the entire length of the study
* Childrens' body weights will not vary by more than 10-15 kg (so that dose per kg is comparable within the two dosing groups)
Exclusion Criteria
* Documented GI disorders (e.g., Crohn's disease)
* A serious chronic medical condition (e.g., diabetes)
* A weight and/or height \< 2 SD for age
* Chronic conditions with GI symptoms (e.g., cystic fibrosis)
* Autism spectrum disorder, significant developmental delay, psychosis, depression, or a history of bipolar disorder
* Antibiotic/probiotic treatment within 2 mo.
* Allergy/sensitivity to PMO or its ingredients
* Inability to swallow the PMO capsule or the SmartPill®
* Inability to speak English - testing materials are available only in this language
* Unable to discontinue laxative, prokinetic, or neuromodulator from 3 wk prior to Visit 1 through the end of the study
7 Years
12 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Robert Shulman, M.D.
Professor
Principal Investigators
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Robert J Shulman, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Locations
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Children's Nutrition Research Center
Houston, Texas, United States
Countries
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Other Identifiers
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H-40351
Identifier Type: -
Identifier Source: org_study_id